A Phase III, Randomised, international trial comparing mFOLFIRINOX triplet chemotherapy to mFOLFOX for high-risk stage III colon cancer in adjuvant setting - IROCAS

Phase 1

Active, not recruiting

• Conditions: High-risk stage III colon cancer in adjuvant setting; MedDRA version: 19.0Level: PTClassification code 10009955Term: Colon cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001491-29-FR
• Lead Sponsor: ICANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-23
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

1.Patient =18 years and < 71years
2.Patient with ECOG =1
3.Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to pT4N1 or pT1-4N2 tumor.
4.Curative R0 surgical resection within 42 days before randomization.
5.Patients who have undergone surgery for colon cancer, defined as a tumor location >12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery (high rectum), without gross or microscopic evidence of residual disease after surgery with curative intent
6.Start of study drug treatment has to be performed less than 56 days after surgery.
7.No prior chemotherapy.
8.No prior abdominal or pelvic irradiation.
9.Patient with adequate organ function:
?Absolute neutrophil count (ANC) =1.5 x 109/L
?Haemoglobin =9 g/dL
?Platelets (PTL) =100 x 109/L
?AST/ALT =2.5 x ULN
?Alkaline phosphatase =2.5 x ULN
?Total Bilirubin =1.5 x ULN (Upper Limit of Normal)
?Creatinine clearance =50 mL/min (Cockcroft and Gault formula)
?Carcinoembryogenic antigen (CEA) =10ng/mL after surgery (during screening period)
10.Adequate contraception if applicable.
11.Patient able and willing to comply with study procedures as per protocol
12.Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures
13.Public or private health insurance coverage
14.Life expectancy of > or = at 5 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

1.Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study
2. Metastatic disease
3.Presence of inflammatory bowel disease
4.Known hypersensitivity reaction to any of the components of study treatments.
5.Pregnancy (absence to be confirmed by ß-hCG test) or breast-feeding period
6.Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
7.Previous malignancy in the last 5 years except curative treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
8.Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
9.History or current evidence on physical examination of central nervous system disease or peripheral neuropathy = grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v4.03.
10.Any significant disease which, in the investigator’s opinion, would exclude the patient from the study.
11.Known DPD deficiency or UGTA1A1 homozygous 7/7
12.Patients already included in another therapeutic trial involving an experimental drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the 3-year Disease Free Survival rate.;Secondary Objective: •Evaluation of Efficacy: Disease-free-Survival at 2 years. <br>•Overall Survival (OS)<br>•Evaluation of Toxicity<br>;Primary end point(s): The primary end-point is the Disease Free Survival (DFS) at 3 years, defined as the time from the date of randomization up to the date of:<br>-first local, regional or distant relapse;<br>-second colorectal cancer;<br>-death from any cause included treatment-related death.<br>Other primary cancer (except second primary colorectal) will be ignored. Second primary cancer will be recorded to have the opportunity of evaluating other definition of DFS.<br>;Timepoint(s) of evaluation of this end point: 3 years from the date of randomization